The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

6251–6275 of 29111

  • SevereNHTSA·22V637000·2022-08-24

    New Flyer Transit Buses Recalled for Steering Gear Fracture Risk

    New Flyer is recalling 2021-2022 transit buses because incorrectly assembled steering gears may fracture, potentially causing a loss of steering control.

    Product
    NEW FLYER — NEW FLYER XD40, XE40, XN40, XN35
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1594-2022·2022-08-24

    14% Chocolate Base Mix recalled for potential Listeria monocytogenes contamination

    Kingdom Creamery of Vermont is recalling 1,623 cases of 14% Chocolate Base Mix (Lot 220724, Best By Date 8/11/22) distributed in VT, ME, and MA due to potential Listeria monocytogenes contamination.

    Product
    14% Chocolate Base Mix; Kingdom Creamery of Vermont
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1589-2022·2022-08-24

    Kingdom Creamery of Vermont Maple Soft Serve Mix Recalled for Listeria

    Kingdom Creamery of Vermont's 10% Maple Soft Serve Mix is being recalled due to potential Listeria monocytogenes contamination. The affected product was distributed in Vermont, Maine, and Massachusetts.

    Product
    Kingdom Creamery of Vermont 10% Maple Soft Serve Mix
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1557-2022·2022-08-24

    Albertsons Ready Meals Snow Crab Legs Imitation Surimi Recalled for Undeclared Allergens

    Albertsons Companies LLC is recalling Ready Meals Snow Crab Legs Imitation Surimi (UPC 23463900000) for undeclared fish, shellfish, egg, and wheat allergens. Affected products have sell-through dates up to July 18.

    Product
    Ready Meals Snow Crab Legs Imitation Surimi SCE NET WT 12 OZ CAL 300 NET WT. 0lb 12oz (340g) ready2eat Tomato paste, water, high fructose corn syrup, distilled vinegar, horseradish, salt, lemon juice concentrate, soybean oil, beet powder, natural and artificial flavor, zanthan g
    Category
    Food
    Distribution
    25 states
  • SevereNHTSA·22V634000·2022-08-19

    Thomas Built Buses Recalls Saf-T-Liner HDX School Buses for Seat Barrier Defect

    Daimler Trucks North America is recalling 2011-2021 Thomas Built Saf-T-Liner HDX school buses because forward seat barriers may not provide sufficient protection, increasing injury risk in crashes.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER HDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1400-2022·2022-08-17

    Viral Transport Container Distributed Without FDA Clearance or Guidance Compliance

    Haimen Shengbang Laboratory Equipment recalled 100,000 viral transport containers distributed without FDA clearance and outside FDA guidance, affecting facilities in California, Florida, Illinois, New York, and China.

    Product
    HXBL/WETEX/Genesis Biomedical Viral Transport Container, Custom Made
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1488-2022·2022-08-17

    Cobalt Implantable Defibrillators May Deliver Reduced Shock Energy

    Medtronic Cobalt implantable cardioverter defibrillators may deliver approximately 79% of programmed shock energy during high-voltage therapy. The reduced energy could affect device performance in patients requiring defibrillation.

    Product
    Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt HF CRT-D, Model Numbers: DTPB2D4, DTPB2D1; b. Cobalt HF Quad CRT-D, Model Numbers: DTPB2QQ, DTPB2Q1
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1490-2022·2022-08-17

    Crome Implantable Cardioverter Defibrillators may deliver reduced shock energy

    Medtronic recalls 866 Crome implantable defibrillators due to potential reduced shock energy delivery during high-voltage therapy, affecting devices worldwide. Patients should contact their physician to determine if their device is affected.

    Product
    Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Crome HF CRT-D, Model Numbers: DTPC2D4, DTPC2D1; b. Crome HF Quad CRT-D, Model Numbers: DTPC2QQ, DTPC2Q1
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1485-2022·2022-08-17

    Cobalt Implantable Cardioverter Defibrillators recalled for reduced shock energy

    Medtronic's Cobalt implantable cardioverter defibrillators may deliver approximately 79% of programmed shock energy during high-voltage therapy. Patients with affected models should contact their physician.

    Product
    Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4; b. Cobalt XT DR ICD, Model Numbers: DDPA2D1, DDPA2D4
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1486-2022·2022-08-17

    Medtronic Cobalt Implantable Defibrillators Recalled Due to Reduced Shock Energy Defect

    Medtronic has recalled 8,429 Cobalt implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) worldwide due to potential reduced shock energy during therapy, potentially delivering 79% of programmed energy.

    Product
    Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt XT HF CRT-D, Model Numbers: DTPA2D4, DTPA2D1; b. Cobalt XT HF Quad CRT-D, Model Numbers: DTPA2QQ, DTPA2Q1
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1398-2022·2022-08-17

    FDA Recalls Viral Transport Containers Distributed Without Clearance

    FDA recalls approximately 8.7 million viral transport containers that were distributed without regulatory clearance and without complying with FDA guidance for proper viral transport specifications.

    Product
    HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59 Activated Type
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1542-2022·2022-08-17

    Big Olaf frozen ice cream recalled for potential Listeria monocytogenes contamination

    Big Olaf frozen ice cream products in all flavors and sizes distributed in Florida and Ohio are being recalled due to potential Listeria monocytogenes contamination. Listeria can cause serious illness.

    Product
    Big Olaf, Frozen Ice Cream to include all flavors, sold in sizes 2.5 gal, 1/2 gal, and pints packaged in plastic containers.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1489-2022·2022-08-17

    Crome Implantable Cardioverter Defibrillators Recalled for Reduced Shock Energy

    Medtronic is recalling 1,657 Crome implantable cardioverter defibrillators due to potential reduced shock energy during high-voltage therapy. Affected devices may deliver only 79% of programmed energy.

    Product
    Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1, DVPC3D4; b. Crome DR ICD, Model Numbers: DDPC3D1, DDPC3D4
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1399-2022·2022-08-17

    FDA Recalls 3.95 Million Viral Transport Containers Distributed Without Clearance

    The FDA recalled 3.95 million viral transport containers distributed without FDA clearance and in violation of established guidance. The containers were distributed worldwide, including to facilities in California, Florida, Illinois, and New York.

    Product
    HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59-1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1487-2022·2022-08-17

    Cobalt Implantable Cardioverter Defibrillators May Deliver Reduced Shock Energy

    Certain Cobalt implantable cardioverter defibrillators may deliver approximately 79% of programmed shock energy during therapy, potentially reducing treatment effectiveness. Medtronic is recalling affected units worldwide.

    Product
    Cobalt Implantable Cardioverter Defibrillators: a. Cobalt VR ICD, Model Numbers: DVPB3D1, DVPB3D4; b. Cobalt DR ICD, Model Numbers: DDPB3D1, DDPB3D4
    Category
    Medical Device
    Distribution
    0 states
  • SevereNHTSA·22E069000·2022-08-17

    S&B Diesel Fuel Tank Recall for Insufficient Driveline Clearance

    S&B Filters is recalling certain diesel fuel tanks for RAM Mega Cab vehicles due to insufficient clearance that may cause fuel leaks and fire risk.

    Product
    FUEL SYSTEM, DIESEL:STORAGE:TANK ASSEMBLY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·026-2022·2022-08-14

    Home Run Inn Recalls Frozen Meat Pizza Due to Metal Contamination

    Home Run Inn Frozen Foods is recalling approximately 13,099 pounds of frozen meat pizza that may contain metal. No injuries have been reported.

    Product
    Woodridge 31 Copacking Company LLC — Home Run Inn Frozen Foods Recalls Frozen Meat Pizza due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·22V623000·2022-08-12

    Ford Recalls 2021-2022 F-150 Trucks for Driveshaft Fracture Risk

    Ford is recalling 2021-2022 F-150 vehicles because underbody insulators may loosen and damage the driveshaft, potentially causing loss of vehicle control.

    Product
    FORD — FORD F-150
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V622000·2022-08-12

    Seagrave Recalls 2022 Marauder Fire Trucks Due to Steering Gear Defect

    Seagrave is recalling 2022 Marauder fire trucks because incorrectly assembled steering gears may fracture, potentially causing a loss of steering control and increasing crash risk.

    Product
    SEAGRAVE — SEAGRAVE MARAUDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·22199·2022-08-11

    Residential Elevators recalled for child entrapment hazard

    Residential Elevators, Inc. is recalling about 31,000 home elevators sold since 1986 because young children can become trapped between the exterior and interior doors, risking serious injury or death.

    Product
    Residential Elevators
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1350-2022·2022-08-10

    SUSTANGO supplement capsules recalled for undisclosed tadalafil content

    SUSTANGO capsules contain the undisclosed pharmaceutical ingredient tadalafil and were marketed without FDA approval. Approximately 750 cartons were distributed nationwide via Amazon.

    Product
    SUSTANGO (Pendenadril Tytrate Blend) Capsules, 400 mg, 10-count blisters per carton, Formulated by: Male FX Labs, Bangor, ME, ASIN X0024468I9.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1333-2022·2022-08-10

    SANGTER Energy Supplement Capsules Recalled for Undisclosed Sildenafil

    Distributor RFR, LLC is recalling SANGTER Energy Supplement Capsules because FDA analysis found they contain undisclosed sildenafil without FDA approval. The product was distributed nationwide and internationally.

    Product
    SANGTER Energy Supplement Capsules, 3000mg x 7 grain, 7-count blister pack within a carton, Distributed by: Distributor RFR, LLC, (800) 519-0204 Miami 33172 FL, USA; UPC 0 705632 523285
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V614000·2022-08-10

    BMW Recalls 2018 540D xDrive Vehicles Due to EGR Module Fire Risk

    BMW is recalling 2018 540D xDrive vehicles because an internal leak in the EGR cooler may cause coolant to mix with soot, creating smoldering particles and a melting intake manifold that increases fire risk.

    Product
    BMW — BMW 540D
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1401-2022·2022-08-10

    SARS-CoV-2 Rapid Antigen Test Kits Distributed Without FDA Approval

    North American Diagnostics is recalling SARS-CoV-2 rapid antigen test kits that were distributed without FDA approval or clearance. Approximately 122,366 units were sold to consumers across multiple US states and internationally.

    Product
    SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid Antigen Test, SML LDT Kits, SML Brand Finished Kits, SML Brand BT Test Kits, SML Brand BT Antigen Test Kit LDT
    Category
    Medical Device
    Distribution
    Distributed nationwide